CLINIMIX

Product NDC
0338-7013
11-digit product format
003387013
Labeler code
0338
Product ID
0338-7013_f39f992f-7a22-46f6-9241-f03d349b95d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA020734
Marketing category
NDA
Marketing start
2024-07-15
Substance
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength
1035; 575; 20; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
OF5P57N2ZXALANINE56-41-7ALANINE
94ZLA3W45FARGININE74-79-3ARGININE
TE7660XO1CGLYCINE56-40-6GLYCINE
4QD397987EHISTIDINE71-00-1HISTIDINE
04Y7590D77ISOLEUCINE73-32-5ISOLEUCINE
GMW67QNF9CLEUCINE61-90-5LEUCINE
K3Z4F929H6LYSINE56-87-1LYSINE
AE28F7PNPLMETHIONINE63-68-3METHIONINE
47E5O17Y3RPHENYLALANINE63-91-2PHENYLALANINE
9DLQ4CIU6VPROLINE147-85-3PROLINE
452VLY9402SERINE56-45-1SERINE
2ZD004190STHREONINE72-19-5THREONINE
8DUH1N11BXTRYPTOPHAN73-22-3TRYPTOPHAN
42HK56048UTYROSINE60-18-4TYROSINE
HG18B9YRS7VALINE72-18-4VALINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-7013-06003387013066 BAG in 1 CARTON (0338-7013-06) / 1000 mL in 1 BAG (0338-7013-01) 6 bag2024-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CLINIMIXBaxter Healthcare Corporation | Baxter SA2021-04-13HUMAN PRESCRIPTION DRUG LABEL13